MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NEURAY® PACKING; NEUROSURGICAL PADDIE

Model Number 8004000

Device Problems Material Separation (1562); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: analysis results are not available; no device returned for evaluation.

Event Description

It was reported that during a spinal procedure, "when removing a neuray patty the string detached and came out of the patient and the patty stayed.They x-rayed the patient but the patty was not detected.They used another neuray patty in the patient's wound and performed another x-ray and the new patty was also not detected by the x-ray." the second neuray patty was discarded, the first remains in the patient, or, was possibly discarded with removed tissue.There was no patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: NEURAY® PACKING
• Type of Device: NEUROSURGICAL PADDIE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 5738500
• MDR Text Key: 47839061
• Report Number: 1045254-2016-00197
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8004000
• Device Catalogue Number: 8004000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1